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Carvedilol

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Carvedilol · 2 trials · 1 indication

Phase 1 2
NCT00648622Fed Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mgHealthy
COMPLETED50 Analytics
NCT00650416Fasting Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mgHealthy
COMPLETED50 Analytics
PHASE1COMPLETED
Fed Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg
Healthy
NCT0064862250
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PHASE1COMPLETED
Fasting Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg
Healthy
NCT0065041650
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Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCarvedilol Tablets 12.5 mg
2ACTIVE_COMPARATORCoreg® Tablets 12.5 mg

Interventions

NameTypeDescription
Carvedilol Tablets 12.5 mgDRUG12.5mg, single dose fed
Coreg® Tablets 12.5 mgDRUG12.5mg, single dose fed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ev...

Countries:United States
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